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NCT Number: NCT01354288

Therapeutic Education in Very Young Children With Diabetes Mellitus

DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.

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Key information

Conditions

Type 1 Diabetes Acid-Base Imbalance Acidosis Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

About this study

General frame : 1 inclusion / randomization visit and delivery of the educational tool for patients of the "Therapeutic Education" arm, then follow-up visits every 6 months during 24 months.

V0 - Inclusion / randomization visit - Verification of eligibility - Clinical examination and data report - Blood samples for lab tests (HbA1c assay)- Collection of signed consent form- DIAB-EDUC questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and emergency situations, parental stress)- Randomization - Education tool explanation and delivery by the physicians to parents randomized in " Experimental " arm

M6 - Visit at 6 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M12 - Visit at 12 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

M18 - Visit at 18 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M24 - Visit at 24 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with type 1 diabetes aged 1 to 6 years
  • Disease evolution more than 1 year
  • HbA1c > 8% or at least one acute accident (hypoglycemia or ketosis) during the last year
  • Specific information given to parents from the physicians and consent form signed by the parents
  • Physical examination of the children at enrolment- patient affiliated with or receiving health insurance

Exclusion criteria

  • Non-insulin dependent diabetes
  • Monogenic diabetes (MODY)
  • Severe co-morbidities- cognitive disabilities or psychosocial disadvantage compromising the therapeutic education
  • Children whose parents have a disorder of comprehension or expression of the French Language
  • Patients included in another interventional trial

Treatment and study plan

Educational Tool

Other

Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management

Other names: Experimental

Primary outcomes

  1. HbA1c 12 months after therapeutic education

    Time frame: 12 months

Secondary outcomes

  1. HbA1C 24 months after therapeutic education

    Time frame: 24 months

  2. Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period

    Time frame: 12 and 24 months

  3. Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)

    Time frame: 12 and 24 months

  4. Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)

    Time frame: 12 and 24 months

  5. Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)

    Time frame: 12 and 24 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Therapeutic Education in Very Young Children With Diabetes Mellitus. Evaluation of the Impact of a Specific Tool for Parents on Glycemic Control and Prevention of Acute Events (Hypoglycemia and Ketosis)

Acronym: DIAB-EDUC

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 16, 2011
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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